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Devices
Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
Model / Serial
Lot s 161020, 161021, 161024, 161025, 161027, 161028, 161031, 161101, 161104, 101107, 101108, 161109, 161109, 161110, 161111, 161114, 161121, 161122, 161122, 161123, 161124, 161125, 161128, 161129, 161130, 161206, 161207, 161208, 161209, 161212, 161219, 161220, 161221, 161222, 1612223, 161226, 161227, 161228, 170109, 170112, 170113, 170116, 170117, 170120, 170123, 170124, 170125, 170126, 170127, 170130, 170131, 170201
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 6FR - 10CM (0.021), REF/Product Code RM*RS6F10PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
1 Event
Recall of Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
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Manufacturer
Terumo Medical Corp
Manufacturer Address
Terumo Medical Corp, 2101 Cottontail Ln, Somerset NJ 08873-1277
Manufacturer Parent Company (2017)
Terumo Corp.
Source
USFDA
16 devices with a similar name
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Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
Model / Serial
Lot s 161018, 161116, 161117, 161213, 161214, 170118, 170119
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath A-Kit, 6FR - 10CM (0.025), REF/Product Code RM*ES6J10HAT, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
Model / Serial
Lot s 161019, 161115, 161212, 170112
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*RS5F10PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
Model / Serial
Lot s 161107, 170209, 170307, 170406
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 16CM (0.021), REF/Product Code RM*RS5F16PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
Model / Serial
Lot 170113
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.025), REF/Product Code RM*RS5J10PA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
Device Recall Glidesheath Slender Hydrophilic Coated Introducer Sheath
Model / Serial
Lot 161104
Product Classification
Cardiovascular Devices
Device Class
2
Implanted device?
No
Distribution
Nationwide and Canada
Product Description
Glidesheath Slender Hydrophilic Coated Introducer Sheath, 5FR - 10CM (0.021), REF/Product Code RM*CS5F10NA, STERILE, Rx ONLY
Manufacturer
Terumo Medical Corp
11 more
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